article
The current limitations facing biosimilar products and manufacturers
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
List view / Grid view
Covid-19
news
EU regulators release medicine demand forecasting guidance for future crises
The new recommendations, developed in the context of the COVID-19 pandemic, are designed to help countries and other stakeholders forecast demand of medicines in future pandemics.
news
100 Days Mission: “landmark collaboration” to protect people against future pandemics
Governments and life science leaders agree to work towards slashing the time to develop and deploy interventions and diagnostics for future pandemic threats to 100 days.
news
US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
news
COVID-19 Vaccine Moderna update
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
news
WHO lists the Sinovac-CoronaVac COVID-19 vaccine emergency use
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
news
EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
news
UK approves Janssen COVID-19 Vaccine
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.
news
FDA approves sotrovimab for emergency use in treating COVID-19
The FDA granted emergency use authorisation to the monoclonal antibody sotrovimab as a treatment for mild-to-moderate COVID-19 in certain adult and paediatric patients.
news
Researchers may know the cause of COVID-19 vaccine related blood clots
Investigators at the Goethe University of Frankfurt believe that post-transcriptional modifications may be causing the clotting problems associated with recombinant vector COVID-19 vaccines.
news
First patient dosed with multi-variant second-generation COVID-19 vaccine
The first-in-human trial of OSE Immunotherapeutics’ multi-variant, second-generation COVID-19 vaccine has enrolled and dosed its first participant.
news
Moderna’s COVID-19 vaccine 93 percent effective in adolescents
New Phase II/III study data shows Moderna’s COVID-19 vaccine is safe and immunogenic in patients aged 12 to less than 18 years old.
article
Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
news
Global nebulisers market to decline after COVID-19
As the world recovers from COVID-19, research suggests the nebuliser devices market will initially shrink before recovering and reaching a value of $1.55 billion in 2025.
news
Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
A new report suggests pharma is working hard to combat worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.
